Ignite Creation Date:
2025-12-24 @ 4:49 PM
Ignite Modification Date:
2025-12-27 @ 3:59 AM
Study NCT ID:
NCT06235450
Status:
RECRUITING
Last Update Posted:
2024-02-01
First Post:
2024-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Usability Study of iTEAR100 For Combined EyeLid Microblepharoexfoliation and Neurostimulation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001762', 'term': 'Blepharitis'}, {'id': 'D015352', 'term': 'Dry Eye Syndromes'}], 'ancestors': [{'id': 'D005141', 'term': 'Eyelid Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Open Label, Prospective, Therapeutic Intervention'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-23', 'studyFirstSubmitDate': '2024-01-23', 'studyFirstSubmitQcDate': '2024-01-23', 'lastUpdatePostDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Questionnaire', 'timeFrame': '30 days', 'description': 'How does iLids compare to NuLids product'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['MicroBlepharoexfoliation, NuLids, iTEAR100, iLIDS100, Blepharitis, Dry Eye Syndrome']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the usability of the iTEAR100 generation 2 device in combination with its newly developed iLIDS100 disposable cover.', 'detailedDescription': 'This usability study is meant to validate treatment using the iLIDS100 in patients who already use the NuLids Device and iTEAR100. The patients will simply substitute the iLIDS100 cover in combination with the iTEAR100 for the NuLids product and otherwise maintain their same treatment regimen. The planned number of subjects was chosen to provide clinically relevant usability data'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nMust use iTEAR and NuLids at time of enrollment\n\nExclusion Criteria:\n\n1\\. have any condition, which in the judgment of the PI would prevent a potential subject from safely completing the study or tolerating device use, such as mental illness, dementia, severe agitation, etc. and including inability to comply with the treatment regimen.'}, 'identificationModule': {'nctId': 'NCT06235450', 'briefTitle': 'A Usability Study of iTEAR100 For Combined EyeLid Microblepharoexfoliation and Neurostimulation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Olympic Ophthalmics, Inc.'}, 'officialTitle': 'A Usability Study of iTEAR100 For Combined EyeLid Microblepharoexfoliation and Neurostimulation', 'orgStudyIdInfo': {'id': 'CLP-012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Therapeutic iLIDS arm', 'description': 'Subjects apply iTEAR100 device with iLIDS100 accessory', 'interventionNames': ['Device: iLIDS100']}], 'interventions': [{'name': 'iLIDS100', 'type': 'DEVICE', 'description': 'Subject applies iLIDS accessory to the iTEAR100 device. Applies to Eyelid margin similar to commercial products', 'armGroupLabels': ['Therapeutic iLIDS arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98027', 'city': 'Issaquah', 'state': 'Washington', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Michael Gertner, MD', 'role': 'CONTACT', 'phone': '650-283-9388'}, {'name': 'Michael Gertner, MD', 'role': 'CONTACT', 'email': 'mgertner@oo-med.com', 'phone': '6502839388'}, {'name': 'Michael Gertner, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Olympic Ophthalmics', 'geoPoint': {'lat': 47.5301, 'lon': -122.03262}}], 'centralContacts': [{'name': 'Michael Gertner, MD', 'role': 'CONTACT', 'email': 'mgertner@oo-med.com', 'phone': '650-283-9388'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': '30 days after study completion', 'ipdSharing': 'YES', 'description': 'Full dataset , 30 days after study close'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Olympic Ophthalmics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}